NCT04038489

COX Inhibition and Biomarkers During Neoadjuvant Chemoendocrine Therapy for ER+, HER2- Stage I-III Breast Cancer

COX Inhibition and Biomarkers of Response During Neoadjuvant Chemoendocrine Therapy for Estrogen Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative Stage I-III Breast Cancer

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to assess the safety and clinical activity of tamoxifen and the COX inhibitor, aspirin, given in combination with standard AC-T chemotherapy (doxorubicin, cyclophosphamide, and paclitaxel) for the treatment of high-risk estrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)- breast cancer. If successful, the study could improve long-term outcomes for a subpopulation of women with aggressive stage I-III ER+/HER2- breast cancer.

Conditions

• Breast Cancer
• Estrogen Receptor-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Aspirin	325 mg aspirin daily during AC-T chemotherapy
DRUG	Tamoxifen Pill	Tamoxifen (either 20 mg daily or 10 mg twice a day) during AC-T chemotherapy
DRUG	Doxorubicin	Doxorubicin (60 mg/m2) Given by IV with cyclophosphamide
DRUG	Cyclophosphamide	Cyclophosphamide (600 mg/m2) Given by IV with doxorubicin
DRUG	Paclitaxel	Paclitaxel 80 mg/m2 or 175 mg/m2 based on provider preference. Given by IV after completion of doxorubicin/cyclophosphamide therapy

Timeline

• Start date: 2019-10-18
• Primary completion: 2023-04-30
• Completion: 2023-04-30
• First posted: 2019-07-30
• Last updated: 2021-11-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study